What Concept of Manual Therapy is More Effective?

Not Applicable

Completed

• Conditions: Self Efficacy; Kinesiophobia; Catastrophizing; Central Sensitisation; Quality of Life; Sleep; Anxiety; Depression

• Registration Number: NCT05559021
• Lead Sponsor: Universidad Europea de Madrid

Brief Summary

The aim of the study will be to find out which manual therapy approach is most effective for the improvement of symptoms (sensory, cognitive, emotional and social) in people with Fibromyalgia.

Detailed Description

A randomized clinical trial will be conducted in 52 patients with Fibromyalgia who will undergo a myofascial treatment approach or a passive mobilization treatment approach. Data will be collected on the improvement of symptom severity, quality of life, self-efficacy, kinesiophobia, catastrophizing, central sensitization, anxiety, depression, and sleep. After the treatments, follow-ups will be made, and the results are expected to be disseminated to the scientific community during and after the end of the study.

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-29
• Study Start: 2022-10-20
• Primary Completion: 2023-09-15
• Study Completion: 2023-12-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-10
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• Less than 62 years old
• Medical Diagnosis of Fibromyalgia
• The individuals included in the study had a minimum one-year history of symptoms
• To confirm the medical diagnosis of fibromyalgia, the physical therapists and study investigators used the 2010 American College of Rheumatology (ACR) diagnostic criteria. -Since 2 of the measurement variables used in the study (WPI and SS-Score) match the protocol when determining these criteria, this procedure was facilitated.

The diagnostic criteria establish the diagnosis of fibromyalgia when12 : IDG/WPI ≥ 7 and SS ≥ 5 or IDG/WPI 4-6 and SS ≥ 9.

Exclusion Criteria

• Intolerance to touch
• A change of medication in the last 2-3 months
• Agree not to change their medication during the study

Exclusion Criteria:

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire	Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention	Another measurement variable will be the impact of fibromyalgia on quality of life, through the Fibromyalgia Impact Questionnaire (FIQ), a tool translated into Spanish by means of the international translation-retrotranslation recommendations, and whose reliability, validity, adaptation and sensitivity to change have been satisfactorily analyzed in Spanish patients with fibromyalgia. Consists of 19 items that measure three main categories (a) "function" - ten items that as-sess the participant's physical functions that address the participant's ability to perform each activity. This domain is assessed on a 4-point Likert scale, from 0 to 3 (0= always, 1= always, 1= always, 2= always, 3= always). 0 to 3 (0= always, 1= frequently, 2= occasional-ly, 3= never). (b) "Global impact" - composed of two items assessing the number of days in the last week when the participants felt good and the number of days they could not work due to FM symptoms
Pain Expansion	Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention	This will be classified as a continuous numerical variable measured by the Widespread Pain Index (WPI). In this index, the patient has to mark with an x the areas in which he/she has presented pain during the last week
Symptom severity	Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention	This variable will be classified as a continuous numerical variable, measured by the Symptom Severity Index (SSI/SS-Score), composed of two subscales (SS-1 and SS-2) that assess the intensity during the last week of 3 of the main symptoms present in FM (fatigue, unrefreshing sleep and cognitive disorders), as well as the presence/absence of other common symptoms, respectively. The total score of the SSS is the sum total and ranges from 0 to 12. The SSS correlated correlates strongly with the WPI (r=0.733) and with the presence of Tender Points (r=0.680)

Secondary Outcome Measures

Name	Time	Method
Depression	Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention	The Beck Depression Inventory is a useful tool to assess somatic symptoms of depression, both in anxiety disorders and depressive conditions. The questionnaire consists of 21 questions, providing a range of scores between 0 and 63.; The questionnaire proposes the following cut-off scores and corresponding degrees of depression: 0-13 indicates minimal depression, 14-19 mild depression, 20-28 moderate depression and 29-63 severe depression.
kinesiophobia	Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention	For this purpose, we will use the Tampa Kinesiophobia Scale (TSK), also translated and validated in Spanish. It is a 17-item self-report measure that will be used to measure fear of movement. A high score indicates an extreme fear of movement, while a low score indicates a negligible fear of movement.
Self-Efficacy	Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention	For this purpose, we will use the Pain Self-Efficacy Questionnaire, in its Spanish validated version. The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence that people with persistent pain have in performing activities while in pain. The PSEQ is applicable to all presentations of persistent pain. It inquires about the level of self-efficacy in relation to a range of functions, such as housework, socializing, work, as well as coping with pain without medication. The PSEQ is a 10-item questionnaire developed to assess the confidence that people with persistent pain have in performing activities while in pain. The PSEQ is applicable to all presentations of persistent pain. It inquiries about the level of self-efficacy in relation to a range of functions, such as housework, socializing, work, as well as coping with pain without medication.
Anxiety	Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention	The the State-Trait Anxiety Inventory (STAI) questionnaire will be used to assess two independent concepts of anxiety, each with 20 items: Anxiety as a state: assesses a transient emotional state, characterized by subjective, consciously perceived feelings of alertness and apprehension and by hyperactivity of the autonomic nervous system.; Anxiety as a trait: indicates a relatively stable anxious propensity that characterizes individuals with a tendency to perceive situations as threatening.
Quality of life (EQ-5D-5L)	Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention	It will be evaluated by means of the the EuroQol 5-dimensions 5-levels (EQ-5D-5L), which is a generic instrument for measuring health-related quality of life. The patient himself assesses his state of health, in levels of severity by dimensions The first allows the respondent to define the state of health according to the EQ-5D multi-attribute classification system, composed of 5 dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression), and in each of them there are 3 levels of severity (1, 2 or 3).
Sleep quality	Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention	The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-administered questions and 5 questions assessed by the patient's partner or roommate (if available). Only the self-administered questions are included in the score.; The PSQI, developed by the Department of Psychiatry at the University of Pittsburgh in 1988, is a questionnaire that assesses both qualitative and quantitative aspects of sleep quality in the month prior to its administration.; It shows that subjective sleep quality, duration, efficiency, disturbances and daytime dysfunction have better quality in those with moderate and severe impairment; while in those with average and higher performance, higher sleep latencies are observed. The total score is 21, and scores above 5 indicate significant sleep disturbance.
Visual Analog Scale (VAS)	Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention	To evaluate the pain that the patient has, we use the VAS. This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies.

Trial Locations

Locations (2)

Eleuterio A. Sánchez Romero; 🇪🇸 Madrid, Spain

Universidad Europea de Madrid; 🇪🇸 Madrid, Spain